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Sanofi, Regeneron's Dupixent Meets Late-Stage Urticaria Study Goals
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Sanofi (SNY - Free Report) and Regeneron (REGN - Free Report) announced encouraging data from the confirmatory phase III LIBERTY-CUPID C study evaluating their blockbuster drug Dupixent (dupilumab) in chronicspontaneous urticaria (CSU) indication.
Results Confirm Significant Improvement in Itch & Hives
The LIBERTY-CUPID C study enrolled CSU patients aged six years and older who remained symptomatic despite standard-of-care (SOC) antihistamines and were not previously treated with Novartis (NVS - Free Report) /Roche’s (RHHBY - Free Report) Xolair (omalizumab).
The study achieved its primary endpoint — patients who received the Dupixent-SOC combo achieved an average 8.6-point reduction in itch severity compared with a 6.1-point reduction for patients who received a placebo.
It also achieved a key secondary endpoint — patients in the Dupixent group experienced a 15.9-point reduction in itch and hive severity compared with an 11.2-point reduction in the placebo group. Per SNY/REGN, 30% of patients who received the Dupixent-SOC combination achieved complete response (i.e., no urticaria) compared with 18% in the placebo group.
SNY/REGN’s Regulatory Filing Plans
Data from the LIBERTY-CUPID C study confirms the results of the successful phase III LIBERTY-CUPID A study that also evaluated the Dupixent-SOC combination in the same patient population. Based on data from these two studies, Sanofi and Regeneron plan to resubmit a regulatory filing before this year-end seeking label expansion for Dupixent in CSU indication.
Last year, the FDA issued a complete response letter (CRL) to SNY/REGN’s initial filing seeking approval for Dupixent in CSU indication, supported only by data from the LIBERTY-CUPID A study. At the time, the agency requested more efficacy data on the drug in the CSU indication. If approved, the companies believe that Dupixent will be the first targeted therapy for CSU in a decade.
A chronic inflammation disease, CSU can cause sudden and debilitating hives and persistent itch. Per management estimates, more than 300,000 people in the United States suffer from CSU, which is not adequately controlled by SOC antihistamines.
Novartis/Roche’s Xolair is a major player in this space. Following FDA approval in 2014, it became the first injectable biologic indicated for CSU. While NVS and RHHBY develop and co-promote Xolair in the United States, Novartis records all sales of Xolair outside the country.
SNY Stock Performance
Sanofi’s shares have gained 16.9% in the year compared with the industry’s 24.2% growth.
Image Source: Zacks Investment Research
Dupixent Drives Sanofi and Regeneron’s Toplines
Dupixent is a key top-line driver for Sanofi and Regeneron. During first-half 2024, Sanofi recorded €6.14 billion from Dupixent product sales, indicating 27% year-over-year growth. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are likely to be higher. Sanofi expects Dupixent to achieve about €13 billion by this year’s end and a low double-digit CAGR till 2030.
Dupixent is currently approved in the United States and Europe for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic oesophagitis and prurigo nodularis. The drug recently received approval in Europe for a sixth indication — chronic obstructive pulmonary disease (COPD). A regulatory filing is currently under review with the FDA seeking approval for the drug in COPD indication and a final decision is expected before this month’s end.
Regeneron and Sanofi are jointly marketing Dupixentunder a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
REGN Stock Performance
Regeneron’s shares have risen 29.4% year to date against the industry’s 1.0% fall.
Image Source: Zacks Investment Research
Dupixent Meets Study Goal in Bullous Pemphigoid Indication
In a separate press release, Sanofi and Regeneron also reported positive results from the pivotal phase II/III ADEPT study evaluating Dupixent in adults with moderate-to-severe bullous pemphigoid (BP), a rare skin condition.
The study achieved its primary endpoint — 20% of patients who received Dupixent experienced sustained disease remission at 36 weeks compared to 4% for placebo. The study also achieved all key secondary endpoints.
Based on these results, the companies plan to file a regulatory filing with the FDA for Dupixent in BP before this year’s end. If approved, Dupixent would be the first and only targeted medicine to treat this indication in the country.
Image: Bigstock
Sanofi, Regeneron's Dupixent Meets Late-Stage Urticaria Study Goals
Sanofi (SNY - Free Report) and Regeneron (REGN - Free Report) announced encouraging data from the confirmatory phase III LIBERTY-CUPID C study evaluating their blockbuster drug Dupixent (dupilumab) in chronicspontaneous urticaria (CSU) indication.
Results Confirm Significant Improvement in Itch & Hives
The LIBERTY-CUPID C study enrolled CSU patients aged six years and older who remained symptomatic despite standard-of-care (SOC) antihistamines and were not previously treated with Novartis (NVS - Free Report) /Roche’s (RHHBY - Free Report) Xolair (omalizumab).
The study achieved its primary endpoint — patients who received the Dupixent-SOC combo achieved an average 8.6-point reduction in itch severity compared with a 6.1-point reduction for patients who received a placebo.
It also achieved a key secondary endpoint — patients in the Dupixent group experienced a 15.9-point reduction in itch and hive severity compared with an 11.2-point reduction in the placebo group. Per SNY/REGN, 30% of patients who received the Dupixent-SOC combination achieved complete response (i.e., no urticaria) compared with 18% in the placebo group.
SNY/REGN’s Regulatory Filing Plans
Data from the LIBERTY-CUPID C study confirms the results of the successful phase III LIBERTY-CUPID A study that also evaluated the Dupixent-SOC combination in the same patient population. Based on data from these two studies, Sanofi and Regeneron plan to resubmit a regulatory filing before this year-end seeking label expansion for Dupixent in CSU indication.
Last year, the FDA issued a complete response letter (CRL) to SNY/REGN’s initial filing seeking approval for Dupixent in CSU indication, supported only by data from the LIBERTY-CUPID A study. At the time, the agency requested more efficacy data on the drug in the CSU indication. If approved, the companies believe that Dupixent will be the first targeted therapy for CSU in a decade.
A chronic inflammation disease, CSU can cause sudden and debilitating hives and persistent itch. Per management estimates, more than 300,000 people in the United States suffer from CSU, which is not adequately controlled by SOC antihistamines.
Novartis/Roche’s Xolair is a major player in this space. Following FDA approval in 2014, it became the first injectable biologic indicated for CSU. While NVS and RHHBY develop and co-promote Xolair in the United States, Novartis records all sales of Xolair outside the country.
SNY Stock Performance
Sanofi’s shares have gained 16.9% in the year compared with the industry’s 24.2% growth.
Image Source: Zacks Investment Research
Dupixent Drives Sanofi and Regeneron’s Toplines
Dupixent is a key top-line driver for Sanofi and Regeneron. During first-half 2024, Sanofi recorded €6.14 billion from Dupixent product sales, indicating 27% year-over-year growth. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are likely to be higher. Sanofi expects Dupixent to achieve about €13 billion by this year’s end and a low double-digit CAGR till 2030.
Dupixent is currently approved in the United States and Europe for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic oesophagitis and prurigo nodularis. The drug recently received approval in Europe for a sixth indication — chronic obstructive pulmonary disease (COPD). A regulatory filing is currently under review with the FDA seeking approval for the drug in COPD indication and a final decision is expected before this month’s end.
Regeneron and Sanofi are jointly marketing Dupixentunder a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
REGN Stock Performance
Regeneron’s shares have risen 29.4% year to date against the industry’s 1.0% fall.
Image Source: Zacks Investment Research
Dupixent Meets Study Goal in Bullous Pemphigoid Indication
In a separate press release, Sanofi and Regeneron also reported positive results from the pivotal phase II/III ADEPT study evaluating Dupixent in adults with moderate-to-severe bullous pemphigoid (BP), a rare skin condition.
The study achieved its primary endpoint — 20% of patients who received Dupixent experienced sustained disease remission at 36 weeks compared to 4% for placebo. The study also achieved all key secondary endpoints.
Based on these results, the companies plan to file a regulatory filing with the FDA for Dupixent in BP before this year’s end. If approved, Dupixent would be the first and only targeted medicine to treat this indication in the country.
Sanofi Price
Sanofi price | Sanofi Quote
Regeneron Pharmaceuticals, Inc. Price
Regeneron Pharmaceuticals, Inc. price | Regeneron Pharmaceuticals, Inc. Quote
Zacks Ranks
Sanofi and Regeneron currently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.